Life Sciences

Spectranetics under investigation

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 15, 2008

The FDA and Immigration and Customs Enforcement executed a search warrant at Spectranetics, according to a company release.

The agencies are investigating:
  • Promotion, use, testing, marketing, and sales of certain company products for the treatment of in-stent restenosis, payments made to medical personnel and an identified institution for this application
  • Promotion, use, testing, experimentation, delivery, marketing, and sales of catheter guidewires and balloon catheters manufactured by certain third parties outside of the United States
  • Two post-market studies completed from 2002 to 2005 and payments to medical personnel in connection with those studies
  • Compensation packages for certain of the company’s personnel

In its release, Spectranetics said it is cooperating fully with investigators.

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